EBS (ESPE BONDING SYSTEM)— 510(k) K962428

Substantially Equivalent

Espe GmbH & Co. Kg.

FDA 510(k) clearance K962428 for EBS (ESPE BONDING SYSTEM), Substantially Equivalent on 1996-09-12. Applicant: Espe GmbH & Co. Kg.. Device class: 2.

Clearance details

Applicant: Espe GmbH & Co. Kg.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1996-06-24
Decision date: 1996-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seefeld, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from Espe GmbH & Co. Kg.

K974231 — POSITION PENTA, POSITION PENTA QUICK1998-01-29
K973513 — SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER1997-12-22
K973262 — KETAC-FIL APLICAP PLUS1997-11-17
K972892 — CAVIT-LC1997-10-02
K963735 — COJET SYSTEM1996-11-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.